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  • ipar4s2 ipar4s2 Dec 27, 2005 4:13 PM Flag

    BIIB / Lazard part 1

    PK We're going to get started. We actually web cast our Q&A sessions, so in the future if you don't get to the conference you can always listen to the Q&A on web cast as well to make sure everybody can hear whatever is going on. So I think we're getting ready to start. Yes, go ahead.

    PK: No, the question can I comment on compassionate use to TYSABRI. We are not, no one is being dosed right now, so all dosing of the drug was suspended in February 28th. We're currently in discussions with the FDA to restart dosing for the MS patients who'd been in the trials, and we would then move on to Crohn's at some point after that, but at this point nobody's receiving the drug until all of the safety work has been reviewed by the FDA, but that is an ongoing discussion. We would expect probably to have dosing started before we get through the full approval process.

    Q.When do you expect to hear whether or not you'll be required to have a panel meeting?

    PK: Yes, the question was when do we expect to hear about a panel meeting? We really think that's any time now. It�s up to the FDA to let us know. On the time line we're on they probably would let us know certainly this month, it wouldn't let it drag into next year. Our expectations are that there would be a panel meeting, that's just what we've been assuming.

    Q. December?

    PK: Not a panel meeting in December, but we'd expect--

    Q. You'll know in December.

    Speaker 1: But we'll know in December, and we're planning for it and assuming it will happen. Maybe it wouldn't, but it would be our expectation it probably would. It'd be certainly understandable. It�s a drug that's generated a lot of physician and patient interest and certainly the safety data's new. There's a discussion what the label should say and what kind of activity should be happening with the risk mapping. I think all of that would be kind of discussed before the FDA comes back.

    PK [Much interesting] question, so the question was have we thought we PDL deal combining in combination therapy a M200 program with TYSABRI? That's really beyond anything we've done at this point. At this point we're kind of at the blocking tackling on M200. It�s an interesting idea and certainly the kind of the thing that we'd be kicking around. We love having the portfolio of products to work with, but at this point it�s probably too early.

    Oscar: At this point actually given that the deal is relatively new, a lot of teams, both teams on both sides are kind of just getting together really re visiting the clinical development plans to kind of carve out a path forward for each of the programs.

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